Anal fistula plug vs mucosa advancement flap in complex fistula-in-ano: A meta-analysis

Background The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis® anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported. Objectives To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon’s preference for the treatment of trans-sphincteric anal fistulas. Design A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial. Setting Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland. Participants Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin. Interventions Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon’s preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure]. Main outcome measures The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness. Results Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon’s preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon’s preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon’s preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon’s preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon’s preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35–45% chance that the fistula plug was as cost-effective as surgeon’s preference over a range of thresholds of willingness to pay for a single QALY of £20,000–30,000. Limitations Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up. Conclusions The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon’s preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS. Future work Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment. Trial registration Current Controlled Trials ISRCTN78352529. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.

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Išangės fistulės kamščio metodo taikymas sudėtingai išangės fistulei gydyti

Lietuvos chirurgija ◽

10.15388/lietchirur.2010.4.2095 ◽

2010 ◽

Vol 8 (4) ◽

pp. 0-0

Author(s):

Edgaras Palubinskas ◽

Narimantas Evaldas Samalavičius ◽

Lina Gudelytė

Keyword(s):

Randomized Controlled Trial ◽

Success Rate ◽

Anal Fistula ◽

Controlled Trial ◽

Fistula In Ano ◽

Randomized Controlled ◽

Fistula Plug ◽

Complex Fistula ◽

Anal Fistula Plug ◽

Vilnius University

Edgaras Palubinskas1, Narimantas Evaldas Samalavičius2, Lina Gudelytė1 1 Vilniaus universiteto Medicinos fakultetas, M. K. Čiurlionio g. 21, LT-03101 Vilnius2 Vilniaus universiteto Onkologijos instituto Chirurgijos klinika ir Vilniaus universiteto Medicinos fakulteto Vidaus ligų, šeimos medicinos ir onkologijos klinika,Santariškių g. 1, LT-08406 VilniusEl. paštas: [email protected] Tikslas: Tyrimo tikslas buvo įvertinti išangės fistulės kamščio (IFK) efektyvumą, gydant aukštas išangės fistules. Metodai: Į apžvalgą iš viso įtraukta 19 darbų iš 31, išspausdinto 2006–2010 m. Iš įtrauktųjų 8 yra retrospektyvinės studijos, 9 prospektyvinės, viena dvigubai akla randomizuota studija ir viena prospektyvinė nerandomizuota kontrolinė studija. Bendras į šias studijas įtrauktų ligonių, gydytų išangės fistulės kamščio metodu, skaičius yra 551. Rezultatai: Pooperacinio stebėjo laikas buvo nuo 3 iki 24 mėnesių. Gydymo išangės fistulės kamščiu sėkmingumas – nuo 15,6 % iki 88 %. Iš 551 IFK gydytų ligonių 300 (54,4 %) pasveiko. Kriptoglanduliarinės kilmės (K) fistulės buvo sėkmingai išgydytos 55,1 % atvejų, o įvairios kilmės (I) – 54,9 %. Neaptikome patikimo ryšio tarp sėkmingo gydymo rezultatų ir paciento lyties, amžiaus, fistulės ilgio ar kilmės. Išvados: Išangės fistulės kamščio metodas yra patikimas gydyti sudėtingas fistula-in-ano. Ateities tyrimai turėtų padėti aiškiau apibrėžti gydymo išangės fistulės kamščiu metodo vietą išangės fistulių chirurgijoje. Reikšminiai žodžiai: fistula-in-ano, išangės fistulės kamštis, ligos atkrytis, tiesiosios žarnos lopas. Anal fistula plug for the treatment of complex fistula-in-ano Edgaras Palubinskas1, Narimantas Evaldas Samalavičius2, Lina gudelytė1 1 Vilnius University Medical Faculty, M. K. Čiurlionio str. 21, LT-03101 Vilnius, Lithuania2 Vilnius University, Institute of Oncology, Clinic of Surgery,Santariškių str. 1, LT-08406 Vilnius, LithuaniaE-mail: [email protected] Purpose: The aim of the study was to evaluate the efficacy of the anal fistula plug (AFP) for the treatment of fistula-in-ano. Methods: A total of 31 studies, published since 2006 to 2010 were extracted and 19 of them were finally included in this systematic review. 8 were retrospective case series, 9 prospective studies, 1 prospective non-randomized controlled trial and 1 randomized controlled trial. In these 19 studies, a total of 551 patients were included, who were treated with anal fistula plug. Results: The follow-up period ranged from 3–24 months. The AFP procedure had a success rate ranging from 15.6–88 %. From 551 patients treated with AFP, 300 (54.4 %) were cured. The success rate in patients with cryptoglandular origin (K) was 55.1 % and the success rate in patients with fistulas of other origin was 54.9 %. We did not notice difference in success rate between age, gender, fistula anatomy and etiology. Conclusion: The anal fistula plug method is a reliable method in treat of complex fistula-in-ano. Future studies should help to clarify the place of anal fistula plug in anal fistula surgery. Key words: Fistula-in-ano, anal plug, recurrence, advancement flap.

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